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Monday, November 19, 2012

Government listens to PEALS expert

Newcastle University in England

The expertise and advice of a PEALS academic could result in new, tougher laws on the regulation of medical implants. In the wake of problems with metal on metal hip implants, which were investigated by Dr Pauline McCormack (PEALS) and Professor Tom Joyce (Mechanical & Systems Engineering, Newcastle University), and then the PIP breast implant scandal, the Government launched an investigation into how implants are regulated.

Dr McCormack and Professor Joyce were asked to give evidence to the Science and Technology Select Committee and their recommendations have been accepted by the committee in its report, released this week. The report could lead to new laws if Parliament gives approval.

Pauline investigated the views of people with failed metal on metal hip implants and explored their thoughts on the current system of medical device regulation, including how the system could be improved for the future. These views were presented to the Select Committee in written and oral evidence. Currently there is little transparency over how medical implants were approved for use, the results of any pre-clinical experiments and who approved them. Also failed implants are often just thrown away so there is no chance to learn why they may have failed. This was deemed unacceptable by Professor Joyce and Dr McCormack and the Select Committee agreed.

Pauline said: “To our knowledge we’re the only people working directly with affected patients to research the impacts of their hip implant failures and so we thought it was crucial that we present our findings to the Committee. We highlighted patients’ disappointment with the current system of regulation and testing which was causing unnecessary suffering and adding cost to the NHS. There are ongoing reviews into medical device regulation at the EC in Brussels and the FDA in America so our findings have the potential for wide-ranging impact if the report is accepted by Parliament and if other countries follow that lead.”

PEALS have been collaborating with Newcastle University’s bioengineering team led by Professor Joyce who began investigating the problem of metal hips as far back as 2008.
If you have a failed metal on metal hip implant and would like to contribute to the research, you can complete a questionnaire about your experiences here.